Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study

Background: Limited data exist comparing the effectiveness and safety of rivaroxaban and warfarin in patients with right ventricular dysfunction (RVD), a common acute pulmonary embolism (PE) complication. Objectives: To assess the effectiveness and safety of rivaroxaban compared with warfarin among...

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Main Authors: François Laliberté, Behnood Bikdeli, Veronica Ashton, Guillaume Germain, Julien Boudreau, Manasvi Sundar, Sean D. MacKnight, Brahim Bookhart, Dereck Wentworth, Shawn Murphy, Yichuan G. Hsieh, Gregory Piazza
Format: Article
Language:English
Published: Elsevier 2025-07-01
Series:Research and Practice in Thrombosis and Haemostasis
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Online Access:http://www.sciencedirect.com/science/article/pii/S2475037925002754
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Summary:Background: Limited data exist comparing the effectiveness and safety of rivaroxaban and warfarin in patients with right ventricular dysfunction (RVD), a common acute pulmonary embolism (PE) complication. Objectives: To assess the effectiveness and safety of rivaroxaban compared with warfarin among patients with PE and RVD. Methods: Adult patients newly prescribed rivaroxaban or warfarin during PE-related hospitalization with evidence of RVD were identified from Mass General Brigham’s Research Patient Data Registry database (January 2013-May 2023). Outcomes included time-to-first recurrent venous thromboembolism (VTE) and time-to-first major bleeding event. The proportion of international normalized ratio (INR) measurements within therapeutic range (INR: 2-3) while on warfarin was described. Kaplan–Meier analysis described event rates at 6-month intervals up to 36 months, which were compared using hazard ratios, 95% CIs, and P values from Cox proportional hazards models. Results: Overall, 246 rivaroxaban and 315 warfarin users were included (mean age, 63 years; female: 53%). Median time of treatment was 270 and 235 days for rivaroxaban and warfarin users, respectively; 50.9% of INR measurements among warfarin users were within therapeutic range. Rivaroxaban was associated with significantly lower risk of VTE recurrence than warfarin at all-time points, including 41% lower risk at 36 months (20.4% vs 30.3%; hazard ratio [95% CI], 0.59 [0.38, 0.92]). There was no significant difference in risk of major bleeding between cohorts up to 36 months of treatment (8.2% vs 13.6%). Conclusion: Rivaroxaban was associated with lower risk of recurrent VTE compared with warfarin, without a significant difference in risk of major bleeding.
ISSN:2475-0379